1MoreStep: An Intervention to Increase HIV Care Engagement and Reduce Intimate Partner Violence Among Black Women Living With HIV

NCT05608421 | Recruiting DMC

• 2 other identifiers: IRB00350026R34MH124586-01A1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study tests a 5-session cognitive behavioral approach program (herein referred to as the 1MoreStep intervention) to train Black women living with HIV (BWLWHI) and exposed to intimate partner violence (IPV) in the past 2 years (hereafter, BWLWHI) in: 1) cognitive and behavioral skills to access internal and external sources of strength (e.g. self-reliance, safety net); safety strategies, knowledge about Undetectable = Untransmissible (U=U) and HIV care; and reduce internalized and anticipated stigma; 2) communication skills to respond to enacted HIV and IPV stigma and enlist social support; and 3) addressing structural barriers to HIV care engagement with an HIV navigator component. The intervention is informed by the HIV-Stigma Framework and a resilient-reintegration model which views women as active participants in responding to IPV and managing life with HIV. Aim 1: Examine preliminary efficacy of the 1MoreStep intervention on: (a) IPV safety strategies (informal and formal resources, safety planning, and placating strategies at baseline, 3-month and 6-month follow-up visits); and (b) HIV care engagement (medical record confirmed visit with an HIV care provider, antiretroviral therapy (ART) prescription, medication adherence, and viral load status during 3-month and 6-month follow-up visits). Aim 2: Examine the acceptability and feasibility of the 1MoreStep intervention operationalized by (a) quantitative measures: session attendance and fidelity to key intervention components and (b) qualitative interviews to assess: program fit, facilitators and barriers to participation, and using 1MoreStep intervention skills.

Conditions

HIV; Stigma, Social; Engagement, Patient; Medication Adherence; Violence, Domestic

Keywords

HIV; Intimate Partner Violence (IPV); Black women; Cognitive behavioral approach; Randomized Control Trial (RCT)

Outcome Measures

Primary Outcomes (4)

• Acceptability of study as measured by the Treatment Acceptance Scale

  This scale has scores that range from 8 to 40. Low acceptability scores will be between 8 and 24, and high acceptability scores will be between 17 and 40.

  Week 7

• Acceptability of study as measured by the Treatment Acceptance Scale

  This scale has scores that range from 8 to 40. Low acceptability scores will be between 8 and 24, and high acceptability scores will be between 17 and 40.

  3 month follow up

• Acceptability of study as documented in in-depth interviews

  Interviews will assess program fit, facilitators and barriers to participation, and use of 1MoreStep intervention skills.

  3 month follow up

• Feasibility of study as measured by session attendance

  Session attendance

  Week 7

Secondary Outcomes (5)

• Change in Intimate Partner Violence safety strategies as measured by the Intimate Partner Violence Safety Strategies Index

  Baseline, Week 7 and 3 month follow up

• Change in Self-reported HIV Care Engagement in the form of ART medication use

  Baseline, Week 7 and 3 month follow up

• Change in Use of prescription ART medication as assessed by chart review of HIV Care Engagement

  Baseline, 3 month follow up and 1 year

• Change in Number of HIV Care Provider visits as assessed by self-reported HIV Care Engagement

  Baseline, Week 7 and 3 month follow up

• Change in Number of HIV Care Provider visits as assessed by Chart review of HIV Care Engagement

  Baseline, 3 month follow up and 1 year

Study Arms (2)

1MoreStep Intervention

EXPERIMENTAL

The intervention arm is 8 sessions (7 group and one individual) that meet weekly with a community health educator who is a Black woman and has experience implementing prior behavioral interventions with people who have experienced trauma and/or are LWH.

Behavioral: 1MoreStep

Equal Attention Control

ACTIVE COMPARATOR

The Equal Attention Control consists of 8 sessions (7 group and one individual) that meet weekly for 60-90 minutes. The control sessions provide equal attention and psychotherapeutic experience of a support group where participants can address issues important in their lives.

Behavioral: 1MoreStepControl

Interventions

1MoreStep BEHAVIORAL

Cognitive behavioral intervention to reduce HIV and IPV stigma.

1MoreStep Intervention

1MoreStepControl BEHAVIORAL

This is an equal attention control group.

Equal Attention Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Identifies as "cisgender": a cisgender woman is a person who was assigned female at birth and presents as a woman
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cis-gender female
• Black or African American
• ≥ Age 18
• Living with HIV
• ≤ 1 HIV care visit in previous 12 months OR virally unsuppressed (\>50 copies/mL) OR at high risk for poor HIV care adherence (PHQ ≥ 3, Generalized Anxiety Disorder (GAD) ≥ 3, active substance use)
• IPV within the previous 2 years
• Ability to attend in-person for up to 8 sessions
• Do not report immediate severe danger from their partner
• English fluency

You may not qualify if:

• Not a Cis-gender female
• Not Black or African American
• ≤ Age17 or younger
• Not living with HIV
• ≥ 2 HIV care visits in previous 12 months
• No IPV within the previous 2 years
• Inability to attend in-person for up to 8 sessions
• Reports immediate severe danger from their partner
• Not fluent in English

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (2)

• Turan B, Hatcher AM, Weiser SD, Johnson MO, Rice WS, Turan JM. Framing Mechanisms Linking HIV-Related Stigma, Adherence to Treatment, and Health Outcomes. Am J Public Health. 2017 Jun;107(6):863-869. doi: 10.2105/AJPH.2017.303744. Epub 2017 Apr 20.

  PMID: 28426316 BACKGROUND

• Sikkema KJ, Ranby KW, Meade CS, Hansen NB, Wilson PA, Kochman A. Reductions in traumatic stress following a coping intervention were mediated by decreases in avoidant coping for people living with HIV/AIDS and childhood sexual abuse. J Consult Clin Psychol. 2013 Apr;81(2):274-83. doi: 10.1037/a0030144. Epub 2012 Oct 1.

  PMID: 23025248 BACKGROUND

MeSH Terms

Conditions

Social Stigma; Patient Participation; Medication Adherence

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Patient Compliance

Study Officials

• Kamila Alexander

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kamila Alexander

CONTACT

443-287-8529; kalexan3@jhu.edu

Karin Tobin

CONTACT

410-502-5368; ktobin2@jhu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of the two groups for the duration of the study.

Study Record Dates

• First Submitted: October 31, 2022
• First Posted: November 8, 2022
• Study Start: June 26, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)